Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK RX MINI TREK
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
Estimated date.The nc trek is being filed under a separate medwatch report number.It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during an unspecified procedure (s), the mini trek and nc trek device markers were not visible.It is unknown if this occurred with one or more patients.There were no adverse patient effects and there was no clinically significant delay reported.No additional information was provided regarding this issue.
 
Manufacturer Narrative
B3: estimated.D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MINI TREK CORONARY DILATATION CATHETER
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9923990
MDR Text Key186733900
Report Number2024168-2020-03362
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK RX MINI TREK
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-